ClinicalTrials.gov record NCT07558811
Effects of Glucocorticoid Therapy on Renal Function in Patients With PA Complicated by CKD After Adrenalectomy: A Multicenter RCT
Effects of Glucocorticoid Therapy on Renal Function in Patients With Primary Aldosteronism Complicated by Chronic Kidney Disease After Adrenalectomy: A Multicenter Randomized Controlled Trial
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This phase 4 multicenter randomized controlled trial compares short-term postoperative hydrocortisone replacement with conventional management in people with primary aldosteronism who have chronic kidney disease and are planned for unilateral adrenalectomy. Participants are randomly assigned 1:1 to receive hydrocortisone for one month after surgery or to a control group that does not receive the drug. The main outcome is the change in estimated glomerular filtration rate (eGFR) at 12 months after surgery.
What it is studying. The trial is testing whether giving hydrocortisone for one month after adrenalectomy changes kidney function—measured by the change in eGFR at 12 months—compared with conventional postoperative management without hydrocortisone.
What the researchers hope to learn. To determine whether short-term postoperative hydrocortisone replacement influences the change in eGFR at 12 months after adrenalectomy in patients with primary aldosteronism and chronic kidney disease. The results aim to inform postoperative management decisions.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
This multicenter randomized controlled trial plans to enroll primary aldosteronism (PA) patients who meet the following criteria: confirmed unilateral dominant secretion by adrenal vein sampling (AVS), willingness to undergo surgery, and coexisting chronic kidney disease (CKD). Participants will be randomly assigned in a 1:1 ratio to one of two groups. To determine whether short-term postoperative hydrocortisone replacement therapy (intervention group) is superior to conventional management (surgery within 7 days after AVS, control group) in terms of reducing the decline in estimated glomerular filtration rate (eGFR) at 12 months after surgery.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Intervention_1
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Signed and dated informed consent form.
- Age 18-75 years, any gender.
- Confirmed diagnosis of primary aldosteronism (PA): positive PA screening test plus positive saline infusion test or captopril challenge test.
- Imaging findings indicating unilateral adrenal lesion, with adrenal vein sampling (AVS) confirming unilateral dominant secretion consistent with the lesion side, and planned unilateral adrenalectomy.
- Baseline eGFR 30-60 mL/min/1.73 m² OR positive proteinuria.
Exclusion criteria
- Use of hydrocortisone within 3 months prior to AVS.
- eGFR < 30 mL/min/1.73 m², or documented acute kidney injury (AKI) within the past 3 months.
- Overt cortisol-secreting tumor (clinical Cushing's syndrome) or requirement for long-term hormone replacement therapy.
- Severe proteinuria (24-hour urinary protein ≥ 3.5 g or ACR ≥ 300 mg/g).
- NYHA class III-IV heart failure, or acute coronary syndrome or stroke within the past 3 months.
- Severe allergy to hydrocortisone or history of serious adverse reactions to hydrocortisone.
- Pregnancy, lactation, or planned pregnancy in the near future.
- Active malignancy or life expectancy < 1 year.
- Inability to tolerate surgery.
- Inability to comply with follow-up as judged by the investigator, or any other condition deemed unsuitable for study participation.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
After giving informed consent and confirming eligibility (including AVS and baseline kidney tests), participants are randomly assigned to receive either postoperative hydrocortisone for one month or no drug. All participants will undergo the planned unilateral adrenalectomy. Kidney function (estimated glomerular filtration rate) will be measured at baseline and assessed again at 12 months after surgery to compare changes between groups. Participants will attend the surgery and required follow‑up visits for clinical care and study measurements.
How the study is structured. Randomized, open-label, parallel-group interventional trial (phase 4). Participants are assigned 1:1 to either short-term postoperative hydrocortisone or no hydrocortisone and followed to measure kidney function after surgery.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Primary Aldosteronism Due to Adrenal Hyperplasia. Does it apply to my diagnosis?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on congenital adrenal hyperplasia
Important dates
- Study start
- Apr 22, 2026 (estimated)
- Primary completion
- Dec 31, 2026 (estimated)
- Study completion
- Dec 31, 2028 (estimated)
- Target enrollment
- 90 participants (estimated)
- Last updated on registry
- Apr 30, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Ruijin Hospital
- Principal investigator
- Xu jianzhong, physician
Ruijin Hospital
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins.
Terms used on this page · explanations by MedicalUpdates.ai
- randomized
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- 1:1
- How many participants go to each group. In a 2:1 ratio, two are assigned to the first group for every one assigned to the second.
- control group
- The group the study treatment is compared with. It may receive a placebo, an existing treatment (active comparator), a sham procedure, or no intervention.
- estimated glomerular filtration rate
- A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- life expectancy
- Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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